PATRICIA BRADY320 Russell Street, Carlisle, MA 01421 | (C) 858-531-7812 | pat_brady2003@yahoo.com Linkedin profile: https://www.linkedin.com/in/patricia-brady

PROFESSIONAL SUMMARY

Senior Supply Chain leader with extensive experience and proven results in end to end supply chain management in the pharmaceutical, medical device and diagnostics business sectors. Experienced with developing supply chain management infrastructure and implementation of strategic supply chain functions. Demonstrated ability to lead, contribute and motivate teams to achiever results.

SKILLS Commercial pharmaceutical drug product launches

in the U.S. and EU. Clinical supplies management IND, NDA and EMEA preparation for CMC Development and execution of strategic sourcing, GMP supplier qualification, Master Supply and

Quality Agreements

Implementation of CMC supply chain strategy, master scheduling, material and production planning, ERP systems and financial reporting.

Cold chain product logistics, design and validation of packaging and shipping containers

Artwork development and management CMO selection and management

WORK HISTORY

Flexion Therapeutics / Burlington, MA September 2015 – January 2017Sr. Manager of Supply Chain

Successfully managed the clinical supply chain network, label development, package design, IVRS system and clinical shipments to sites for various clinical studies.

Developed new program prompts to the Fusion eClinical and IWRS system to improve the accuracy of site transactions. Resolved clinical inventory data upload issue with the software developer.

Created outstanding relationship with the clinical packaging and distribution CMO to deliver product to sites in 2 weeks from the time of drug receipt.

Led extensive clinical CMO RFP process to establish the lowest cost, highest level of capabilities and highest quality CMO for worldwide clinical drug distribution.

Provided essential supplier technical data and DMF letters of authorization to support to the CMC section of the Zillretta™ NDA submission filed Dec. 2015.

Established Master Supply Agreements with suppliers for critical components. Delivered innovative solutions from suppliers for next generation product improvement. Established Mass Bio discount program resulting in 40% discount to procure equipment for laboratory space. Led logistic operations for domestic and international shipments including cold chain products. Created standard operating procedure (SOP) for managing new and revised commercial labeling artwork.

Synageva (Alexion) - Lexington, MA May 2015 – August 2015Associate Director of Commercial Supply Chain

Executed packaging product launch time line for Kanuma to assure successful 48 hour product launch from NDA, EMEA approval.

Initiated solution for a label adhesion issue at the CMO, successfully completed the packaging validation. Led the effort to create a commercial MSDS for Kanuma. Initiated the roll out of sales, operations and planning process (S&OP

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Retrophin - San Diego, CA May 2014 – January 2015Associate Director of Procurement and Materials Management

Directed activities related to supply chain management including material sourcing, contract manufacturing relationships, clinical supply management and logistics for rare disease drugs.

Provided supplier based solutions to product development, analytical and commercial operations including a path to procure DEA schedule 3 drugs from a foreign source.

Executed the UAT of VEEVA EDMS Submission Vault as the designated CMC member of the team.

Bioserv Corporation - San Diego, CA March 2014 – May 2014Consultant Director of Supply Chain Management

Performed risk assessment and gap analysis identifying significant weaknesses in procurement and supply chain process to Executive Management. Provided recommendations for improvement.

Renovated the entire procurement and system improving functionality, utilization of ERP software and 100% reduction in AP backlog.

Sequenom - San Diego, CA July 2014 – March 2014Director of Procurement and Supply Chain Management

Directed activities for procurement, strategic sourcing, receiving, master scheduling, production and materials planning, inventory control, warehouse operations, logistics and distribution.

Implemented changes to inbound shipments that resulted in a $1.2 million annual savings. Identified $5 million of potential logistics savings and a $400K reduction in contract packaging cost.

Improved the efficiency of the procurement process by 25% through greater utilization of SAP module, improved collaboration with internal customers and buyer / planner training.

Established optimized process flows, standard operating procedures, best practices, and metrics resulting in a 50% decrease procurement process cycle as well as 100% compliance to SOX requirements.

Reduced open purchase order backlog by 100%. Improved the accuracy of the invoice vs. PO process. Generated $400K in cost savings through negotiations with major suppliers.

Pacira Pharmaceuticals - San Diego, CA March 1995 – July 2013Senior Manager Supply Operations

Initiated and directed end–to-end supply chain functions including procurement, strategic sourcing, master scheduling, S&OP process, production and materials, planning, inventory control, warehouse, and logistics.

Created SOP’s for all supply chain operations. 100% compliance with external regulatory audits Identified and developed supply sources for all raw materials including rare API’s and novel excipients. Successfully led supplier qualification activities to assure multiple sources of supply and reduce risk. Implementation of supply and quality agreements, participated in supplier quality audits. Directed the execution of supply chain, cold chain logistics and manufacturing strategies to successfully launch 3

commercial products in the U.S. and EU. Managed clinical supply chain supporting milestones. Subject matter expert for supplier information required in NDA and EMEA submissions. Directed activities for labeling and packaging CMO’s in U.S. and EU. Executed the development, implementation and management of commercial product labeling. Primary company contact with external marketing and sales partners in the U.S. and EU. Delivered innovative procurement solutions and significant cost savings to internal customers resulting in an

average savings of 20% of all purchase spend per year. Responsible for all company-wide procurement and contracts.

Led packaging engineering projects to design, develop, validate and execute innovative packaging and shipping containers for 2-8’ C temperature sensitive products.

Subject matter expert for ERP implementation, validation and execution

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EDUCATIONBachelor of Arts: PsychologyUCLA, Los Angeles, CA

Certificates: University of San Diego certificates in Project Management and Environmental Health and Safety APICS CSCP certification in process CRM program completion Cal State University San Marcos APICS CPIM certification

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